Real World Solutions, IQVIA, Durham, NC, USA.
Center for Observational and Real-World Evidence, Merck & Co., Inc, Rahway, NJ, USA.
Curr Med Res Opin. 2023 Jul;39(7):997-1006. doi: 10.1080/03007995.2023.2224165. Epub 2023 Jun 24.
Treatment guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimens for treatment naïve people living with HIV (PLWH) in the United States (US). This retrospective database study compared weight changes following initiation of INSTI-, non-nucleoside reverse transcriptase inhibitor (NNRTI)-, or protease inhibitor (PI)-based ART in treatment-naïve PLWH.
Adult (≥18 years) PLWH initiated on INSTI, NNRTI, or PI plus ≥2 nucleoside reverse transcriptase inhibitors (NRTI) between 1 January 2014 to 31 August 2019 were identified in IQVIA's Ambulatory Electronic Medical Records (AEMR) linked to prescription drug claims (LRx). Weight changes over up to 36 months (M) of follow-up were compared among PLWH on INSTI- vs. NNRTI- and PI-based ART separately using non-linear mixed effect models, adjusting for demographics and baseline clinical characteristics.
The INSTI, NNRTI, and PI cohorts included 931, 245, and 124 PLWH, respectively. For all three cohorts, the majority were male (78.2-81.2%) and overweight/obese (53.6-61.6%) at baseline; 40.8-45.2% of the groups were African American. The INSTI vs. NNRTI/PI cohorts were younger (median age: 38 years vs. 44 years/46 years), had lower weight at ART initiation (mean: 80.9 kg vs. 85.7 kg/85.0 kg), and had higher TAF usage during follow-up (55.6% vs. 24.1%/25.8%; all < .05). Multivariate models showed higher weight gain among PLWH in INSTI vs. NNRTI and PI cohorts during treated follow-up (estimated weight gain after 36 M: 7.1 kg vs. 3.8 kg and 3.8 kg, both < .05).
Study findings highlight the need to monitor an increase in weight and potential metabolic complications among PLWH starting ART with INSTI.
治疗指南建议在美国（美国），对于初治的艾滋病毒感染者（PLWH），使用整合酶链转移抑制剂（INSTI）为基础的抗逆转录病毒治疗（ART）方案。本回顾性数据库研究比较了初治的 PLWH 接受 INSTI、非核苷类逆转录酶抑制剂（NNRTI）或蛋白酶抑制剂（PI）为基础的 ART 治疗后体重的变化。
在 IQVIA 的与处方药物索赔（LRx）相关的门诊电子病历（AEMR）中，确定了 2014 年 1 月 1 日至 2019 年 8 月 31 日期间开始使用 INSTI、NNRTI 或 PI 加至少 2 种核苷逆转录酶抑制剂（NRTI）的成年（≥18 岁）PLWH。使用非线性混合效应模型，根据人口统计学和基线临床特征，分别比较了 INSTI-与 NNRTI-和 PI-为基础的 ART 治疗的 PLWH 在长达 36 个月（M）的随访期间体重的变化。
INSTI、NNRTI 和 PI 队列分别包括 931、245 和 124 名 PLWH。对于所有三个队列，大多数在基线时为男性（78.2-81.2%）和超重/肥胖（53.6-61.6%）；40.8-45.2%的人群为非裔美国人。INSTI 与 NNRTI/PI 队列的年龄较小（中位数年龄：38 岁 vs. 44 岁/46 岁），ART 起始时体重较轻（平均：80.9kg vs. 85.7kg/85.0kg），在随访期间 TAF 的使用率较高（55.6% vs. 24.1%/25.8%；均 ＜0.05）。多变量模型显示，在接受治疗的随访期间，INSTI 队列中的 PLWH 体重增加更多（估计在 36 个月后体重增加：7.1kg vs. 3.8kg 和 3.8kg，均 ＜0.05）。
研究结果强调了需要监测开始使用 INSTI 进行 ART 治疗的 PLWH 体重增加和潜在代谢并发症的情况。
